Biopsy devices and methods

ABSTRACT

An improved system for mammography analysis and methods of using the same. In on aspect, the present invention provides a biopsy instrument having a side opening that generally coexists or is aligned with a central portion of a cyst, tissue or otherwise for deploying a marking device to the central region of the same. In another aspect, the present invention provides an encasement, adapted to receive a marking clip, for deployment into a tissue region for marking and/or treatment of the same.

CLAIM OF PRIORITY

The present application is a divisional application of U.S. applicationSer. No. 11/150,666, filed Jun. 10, 2005, which claims the benefit ofthe priority of U.S. Provisional Application Ser. No. 60/579,112 with afiling date of Jun. 11, 2004, all of which are incorporated herein byreference for all purposes.”

Related Application

The present application relates to the subject matter of, and expresslyincorporates by reference, the teachings of commonly owned and inventedU.S. Provisional Patent Application Ser. No. 60/547,844 (filed Feb. 26,2004+ U.S. patent application Ser. No. 10.631,204 (filed Jul. 31, 2003)and PCT/US2003/023995 (filed 31 Jul. 2003).

TECHNICAL FIELD

The present invention relates to devices and methods for performingbiopsies, and more particularly to implantation of breast implantationclips for use as markers in mammography using a cyst aspiration needle.The present invention also relates to marking clips having an encasementfor assisting in the deployment of the clip, the treatment of tissuesurrounding the clip or otherwise as described.

BACKGROUND OF THE INVENTION

Percutaneous biopsy of the breast is a well-accepted alternative to opensurgical biopsy with needle localization for those lesions seen bymammography or ultrasound but not able to be felt by the surgeon. Whenpercutaneous biopsy is performed, it is frequently necessary to place ametal clip at the site of biopsy. This is done for several reasons. Forexample, the lesion biopsied might by partially or entirely removed. Ifthe lesion is proven to be malignant, it is necessary to subsequently doa wide excisional biopsy after needle localization to remove anyresidual malignancy. The clip make the site of biopsy apparent, assuringaccurate localization. In addition, if something is seen on bothmammography and ultrasound, it is not always certain that the lesionsare one and the same. A biopsy under ultrasound guidance with placementof a clip allows confirmation by mammography that the lesion is the sameor different than the one seen on the mammogram. Further, the presenceof a clip seen on a mammogram alerts the radiologist that a biopsy hasbeen performed, prompting the radiologist to more closely evaluate thesite of biopsy.

The vast majority of percutaneous breast biopsies are performed underart-disclosed stereotactic guidance techniques, and generally use adevice known as the Mammotome® (by Johnson & Johnson). The clip that isemployed is generally prone to pinching a minute amount of breasttissue. Sometimes, the clip may fail to hold onto the tissue or the clipmay migrate to a different undesired location.

U.S. Surgical has produced a clip from a wire with a memory that isdelivered into the breast and forms a ring. It is larger in diameterthan the Mammotome® device clip and can grab significantly more tissue.The clip is an alloy containing nickel. Recent indication are the U.S.Surgical may no longer manufacture this clip, thus creating a potentialsupply issue for existing users.

SenoRx, Inc. produces metal markers embedded in Gelfoam pellets (aproduct that promotes clotting of blood), called Gel Mark™. The productis packaged to include a plurality of pellets and one radiographicmarker. The pellets, however, potentially result in undesired migrationof particle.

Although there is current production of a hand-held Mammotome® device,for the purpose of ultrasound guided biopsy, for some users this devicemay be awkward and cumbersome to use. The majority of ultrasound-guidedbiopsies are done with use of Tru-cut needles. This can be done througha coaxial needle. A Bard 12 gauge biopsy needle could be used throughand 11 gauge coaxial needle. Through this 11 gauge coaxial needle, aU.S. Surgical clip might also be delivered, although U.S. Surgical isnot believed to have marketed their clip for use duringultrasound-guided biopsies.

Another product is manufactured by Inrad. This clip is used forplacement during ultrasound-guided biopsy because the delivery device issteel and does not provide the flexibility necessary for deliverythrough the Mammotome® needle. This delivery device has a beveled tip,allowing advancement through breast tissue without a coaxial needle.

Breast biopsies using an 11 gauge coaxial needle have been performed.However, most biopsies are typically done using smaller needles, e.g. a14 gauge biopsy needle with 13.5 gauge coaxial needle. Such small sizes,in many environments, however, are believed to be too small toefficiently allow advancement of the delivery device of currentcommercially available clips.

Turning to another consideration, when a cyst in the breast isaspirated, a spectrum of different types of fluid can be recovered.These might range in color from white to yellow to green or brown. Theymay be mucousy or bloody and thus can be thick or thin. Some physicianssend all samples for cytology analysis, while other physicians may sendonly grossly suspicious samples (e.g. mucousy or bloody). Regardless ofwhich cyst fluids are sent for cytology, once a cyst is evacuated or inthe event that a cyst cannot be fully evacuated because it contains asolid component, a radiologist would like to place a clip into thelesion. It is often important to mark the cyst so that should thecytology prove malignant, or otherwise require further attention, theexact site of the lesion would be known and a needle localization couldbe subsequently performed.

In one particular aspect, with reference to FIGS. 1 a and 1 b, commonprior biopsy instruments generally employ a clip delivery device 1 witha side tube opening 2 having a center “C” disposed within a needle 3.Typically the devices are constructed so that the user needs tolongitudinally re-position the instrument (e.g., on the order of about 5mm to 12 mm or more) between steps of removal of tissue, aspiration of acyst, or both and marking of a biopsy site “A” with a clip 4, in orderto locate the clip precisely in the biopsy site. This is because thedistance “d” from the forward end of a leading portion 5 of the clipdelivery device is less than the distance “D” to a center portion“C_(A)” biopsy site “A”. As seen for example in FIG. 1 b , in order toachieve precise location of the clip at the biopsy site “A”, it isnecessary either to shift the entire needle longitudinally, or toretract the clip delivery device longitudinally, the former being shownin the drawing. Either way, another manual step is required of the user.It is desirous to avoid this need for longitudinal re-positioning, whilestill achieving precise placement of a clip at the biopsy site.

There is a need for improved devices for breast biopsy, cyst aspirationor both, to overcome the above-discussed disadvantages of currentcommercial products.

The following United States patents are also useful to more fullyunderstand the context and application of the present invention and areall hereby expressly incorporated by reference herein: 6,161,034;5,526,822; and 5,649,547. Devices disclosed in the above patents may bemodified as desired to incorporated the inventive features disclosedherein.

SUMMARY OF THE INVENTION

The present invention meets the above needs and contemplates providing abiopsy instrument for use in a manner that does not require longitudinalre-positioning of the instrument within a patient between steps of a)removal of tissue, aspiration of a cyst, or both at a biopsy site and b)marking the biopsy site with a clip, particularly in the context of abreast mammography procedure.

The present invention also provides additional benefits in the markingand/or treatment of a human tissue or otherwise by providing anencasement, adapted to be deployed with a marking clip, comprisingagents used in the treatment of abnormal tissue and/or comprising amaterial suitably adapted for deployment with a clip. It should beappreciated that the encasement of the present invention may be used inany clip deployment device including any device disclosed or referred toherein, and those of the above-incorporated related applications.

DESCRIPTION OF THE DRAWINGS

FIGS. 1 a and b illustrate sectional views of a clip delivery deviceinserted into a cavity of a biopsy site.

FIG. 2 illustrates a sectional view of a clip delivery device of thepresent invention inserted into a cavity of a biopsy site.

FIGS. 3 and 4 illustrates an encasement of the present invention indifferent stages of delivery through a clip delivery device.

FIG. 5 illustrates another encasement of the present invention anotherclip delivery device.

FIGS. 6 a-e illustrates alternate encasement configurations of thepresent invention.

DESCRIPTION OF THE INVENTION

The present invention provides improved devices and methods for themarking and treatment of tissue. Such applications may be particularlyuseful in conjunction with ultrasonic devices used for observing and/ormonitoring specific tissue regions (e.g., breast tissue or otherwise).Such application may be advantageously used with tissue removal andaspiration devices configured for receiving a marking clip deploymentdevice.

In one application, the present invention provides a clip deliverydevice and method for placement of a clip at a specified tissue regionof interest. The device is configured for deployment of a clip at thespecific region without undue manipulation of the device within thetissue. This is particularly useful in conjunction with an aspiratingand/or tissue removal device, formed in part by a hollow needle, whereinthe delivery device is placed within the needle and is configured fordeployment of a clip through a side portion of the device and needle.The device is configured such that when the device is placed within theneedle, the deployed clip will enter a central region of a specifictissue of interest with substantially no adjustment of the deliverydevice within the needle.

Accordingly, the traditional step of movement of the delivery devicewithin a needle to insure proper deployment of the clip at a centralregion of a specific tissue of interest can be substantially eliminated.Furthermore, by deploying the clip to the center region, particularly ina central region of a cyst, the possible entanglement of the clip withthe sidewalls forming the cyst is reduced. This is particularly usefulwhen the marking clip is designed to engage tissue upon deployment andsubstantially limit migration of the clip through tissue. In view of theforegoing, the device simplifies deployment of a marking clip andinsured proper securing and placement of the clip at a predeterminedlocation, particularly a central region of the tissue of interest.

Still other benefits include greater flexibility and control of thedeployment of a clip. The elimination of repositioning of the needleand/or the clip delivery device helps to remove guess work on where orwhen the clip should be deployed as the delivery device is manipulated.Also, this can eliminate the monitoring of any ultrasonic device inorder to determine the position of the deployment device prior todeployment of the device. Accordingly, the delivery device provides amore accurate and reliable clip delivery device.

In another aspect, which may be used with the above deployment device orotherwise, the present invention provides a member used in conjunctionwith a marking clip to protect and/or improve deployment of the clip,provide medicinal benefits, treatments or otherwise. The member isconfigured to be deployed with the clip and preferably is attached orotherwise encloses at least a portion of the clip.

In one preferred configuration the member comprises an enclosureconfigured for encasing at least a portion of the clip, or is otherwiseattached thereto, such that the encasement and clip are simultaneouslydeployed through any of the deployment devices described herein. In theconfiguration, the encasement may be configured for assisting indeployment of the clip. For example, the encasement may be configured toprovide protection of the clip during deployment by acting as anintermediary to the clip and a push rod of the deployment device usedfor deploying the clip. Also, the clip may include an agent forassisting in the deployment of the clip or the agent may include one ormore medicinal agents for treatment of the tissue surrounding the clipof otherwise.

In view of the foregoing , consistent with the teachings of U.S.application Ser. No. 10/631,204 and PCT/US2003/023995, the presentinvention provides a clip delivery device 10 configured for placementwithin a hollow needle 12, preferably (though not necessarily required)having a side opening 14. The needle may be configured for aspiration,tissue removal, a combination thereof or otherwise, which may or may notbe assisted by the side opening. One such delivery device includes atubular member 16 having a hollow opening configured for receiving apushrod 18 or other advancing mechanism. The device includes a sideopening 20 located toward an end portion of the device for deployment ofa clip 22. Accordingly, the side opening of the delivery device isconfigured to align with the side opening of the needle. Still further,upon insertion of the needle and the deliver device within tissue, theopening of the delivery device is coexisting with the center portion ofa biopsy cavity, or otherwise, so that delivery of the clip requireslittle to no longitudinal adjustment of the device prior to deploymentof the clip.

With reference to FIG. 2, the delivery device includes a leading portion24 configured for aligning side opening of the delivery device with theside opening of the needle 12 and more preferably with a central portionof a biopsy site “C_(A)”. As compared with conventional prior devices,the leading portion 24 of the present invention is longer than theleading portions shown in FIGS. 1A and 1B. Accordingly, it is notnecessary to adjust the needle to deploy a clip in the central portionof a biopsy site. Furthermore, it would not be necessary to more thedelivery device within the needle to position the device to deploy inthe central portion of the biopsy site.

More particularly, relative to prior art devices, the present inventioncontemplates moving the side tube opening 20 of the clip deploymentdevice 10 away from the leading portion so that the center “C” of theside opening will be approximately coexisting with a center portion“C_(A)” of the biopsy site “A”. For example, the side tube opening maybe located from the forward end of the leading portion at a distance of5 mm, 10 mm, 15 mm, 20 mm, 25 mm or more. Similarly, the side tubeopening may be located from the forward end of the leading portion at adistance of 5%, 10%, 15%, 20%, 25%, or more of the length of thedelivery device.

In one configuration, this includes moving the side tube openingproximally by about 5-15 mm and more preferably about 10 mm from theforward end of the leading portion 24. For example, as illustrated, thedistance “d” between the forward end of the leading portion 24 and thecenter of the side hole is approximately the same as the distance “D”from the forward end of the leading portion to the center of the biopsysite. In reference to the configuration mention above, this would resultin the distance “d” from the leading portion of the delivery devicebeing about 8 to about 16 mm and even more preferably about 12 mm.

However, it should be appreciated that other configurations areavailable. For example, it is contemplated that multiple deliverydevices may be provided having different distances “d” to correspond tothe distance “D” to the center of the biopsy site “A”. Accordingly, uponinsertion of the needle proximate to the biopsy or cyst site, adeployment device may be selected base upon the size of the biopsy orcyst site. Therefore, with a larger biopsy site or cyst, a deploymentdevice having a greater distance “d” will be selected for insuringdeployment of the clip to a center portion of the site. It should beappreciated that the size of the cyst or biopsy site may be determinedusing common techniques in the field of art, include ultrasonic devices.

One preferred needle 12 that may be used with the delivery deviceincludes any needle having a side opening at a first end and is suitablefor receiving the clip delivery device 10 at a second end. Preferably,the gauge of the needle is about 8 to about 14 and more preferably about11. As such, the gauge of the delivery device being inserted into theneedle is about 9 to about 15 and more preferably about 12. It should beappreciated that the gauge of the delivery device is about 0.5 to about1.5 smaller than the gauge of the needle.

In accordance with the present invention, there are further contemplatedprocesses by which an instrument substantially as disclosed in FIG. 2 isprovided for radiographic analysis, and particularly for mammography.The device is inserted into a breast and a biopsy performed at a biopsysite “A”. Without a positive step of longitudinal re-positioning of theneedle 12 or clip delivery device 10 of the instrument, such as bylongitudinal movement in excess of about 3 mm, a clip 22 is delivered tothe biopsy site “A”.

Thus one method contemplates providing an instrument including a needleand a clip delivery device. The delivery device is inserted into thesecond end of the needle wherein upon insertion the side opening of thedelivery device and the needle are generally aligned. As shown in FIG.2, the needle and delivery device are inserted proximate to a biopsysite wherein the center of the side opening is located proximate to thecenter portion “C_(A)” of a biopsy site “A”. The clip is thereafterdelivered, via pushrod 18, along the hollow portion of the tubularmember 16 in into the center portion “C_(A)” of a biopsy site “A” (e.g.,so at least a portion of the clip overlaps with the biopsy site). Thedelivery of the clip within the biopsy site is essentially free of astep of longitudinal re-positioning by the user of the needle, clipdelivery device, or both, and thus with a greater degree of accuracy ofclip placement.

Alternatively, the needle alone may be inserted proximate to a sitehaving a cyst or to be biopsied. With the needle inserted, on or morefunctions may be performed relating to the treatment or diagnosis of thetissue. Upon completion, the delivery device is inserted into the needlewherein the side opening of the delivery device and needle are generallyaligned. A clip is then deployed as described above.

Upon deployment, the clip engages the surrounding tissue of the formedcyst or biopsy site to substantially prevent the clip from migrating toother portions of the cyst or otherwise. Accordingly, the clipsubstantially remains in the center portion “C_(A)” of a Biopsy site “A”or otherwise. Suitable clips that may be used comprise clips configuredto engage tissue upon deployment. Particularly advantageous clip thatmay be used are clips configured to expand upon deployment to engagetissue. By example, suitable clips that may be used with the presentinvention can be found in commonly owned U.S. patent application Ser.No. 10/631,204 filed Jul. 31,2003, herein incorporated by reference.Other suitable clips can be found herein as shown and described. Suchclips generally include a first portion connected to a second portion atan apex, wherein at least one of the first, second or both portions arestraight, arcuate or include a combination thereof. Such clips aregenerally configured to elastically deform to fit within a deliverydevice and subsequently return to an original shape upon exit.

In another aspect, the present invention further contemplates the use ofan additional member with any of the clips 22 as described or referredto herein, in order to impart an additional function to the resultingimplanted clip. Though the additional member typically will be attachedto a clip, it might be separate from it but deployed during a singledeployment operation (e.g., a single plunger stroke). However,preferably the additional member is in contact with the clip duringdeployment of the same. More preferably, the additional member isadapted to encase all or a portion of clip.

In one aspect, the additional member comprises an encasement 26deployable with a clip. The term encasement may include any object,which includes or comprises agents adapted to assist in the treatment oftissue or any object that assist in the deployment of a marking clip. Assuch, it should be appreciated, though not limiting, that termencasement may include capsules, tablets of the like.

For example, as illustrated in FIGS. 3 and 5, the additional member maycomprises and encasement 26 or other suitable structure adapted toprotect the clip from forces encountered during deployment of the same.As such, when the clip 22 is longitudinally deployed along the deliverytube 16, the encasement absorbs or distributes the load applied by adrive member 18 over a broad region of the clip 22 so as to help preventplastic or permanent deformation of the clip. The encasement may beadapted to prevent direct contact between the drive member and the clip.Additionally, or alternatively, the encasement may further be adapted tocompletely encapsulate the clip so as to prevent contact of the clipwith the surround interior walls of the delivery tube. Therefore, it iswithin the teachings of the present invention to at least, partially (ifnot completely) seal the clip within the encasement, either permanentlyor temporarily (e.g., with a biodegradable or bioerodible medium or thelike, wherein expansion of the clip to a relaxed state occurs after aneffective amount of encasement dissolves or otherwise degrades to allowthe clip to expand therethough).

As demonstrated in FIGS. 1a-B, 2 and 4, upon deployment the clip isconfigured to resist or restrict movement of the clip within thedeployed region (e.g., cyst, biopsy site or otherwise). Therefore, onespecific approach is to provide the encasement 160 so it does notprevent the clip 22 from expanding to its fully relaxed shape.

Alternatively, the encasement 26 may be designed to temporarily orpermanently restrict the clip 22 from attaining its relaxed shaped, orlimits the range of relaxation. For example, it is contemplated that theencasement comprises a material that is biodegradable or bioerodible,which diminishes in volume over time and thus reduces the availabilityof material that will constrain the clip when in an elastically deformedstate. Alternatively, the encasement may comprise a time-releasematerial adapted to diminish in volume, and optionally release one ormore pharmaceutical agents or other agents over time. It should beappreciated that other processes of releasing an encapsulated agent arepossible and within the scope of the present invention.

In yet another aspect, the encasement 26 may be deployed precisely to abiopsy site without a clip 22. It is possible that such encasementmaintains its sized and/or shape over time, or it too might be capableof degrading, eroding or otherwise diminishing in volume.

The preferred dimensions of the encasement are such that any clip 22located therewith fits at least partially, and in one example entirelywithin its volume. For example, referring particularly to FIGS. 3 and 5,optionally the length of the encasement 26 is greater than the length ofthe collapsed clip such that the end portions of the clip are protected.Also as previously discussed, the diameter of the encasement is suchthat the encasement can slidably move within the delivery tube 16 with aminimum amount of surface friction. As such, preferably, the encasementis cylindrical in shape (or otherwise has a complementary or otherwisecompatible shape relative to the delivery tube shape) and has a diameterless than the inner diameter of the delivery tube. Suitable diameters ofthe encasement comprise a range of about between about ⅓ mm to about 2½mm and more preferably about ⅔ mm to about 2 mm. The inside of thedelivery tube also may be treated over at least a portion of its surfacewith a suitable low friction coating (e.g., a polyolefin, or fluorinatedpolymer, such as PTFE might line the tube).

However, it should be appreciated that alternatively the encasement 26may be greater than the interior portion of the delivery tube 16. Forexample, the encasement may be sponge-like or otherwise compressible tofit within the delivery tube. As such, it is contemplated that theencasement may comprise a shape other than cylindrical and may or maynot be symmetrical, geometrical or otherwise systematically configuredmember. Likewise, the encasement may comprise a plurality of components.Examples of various alternate configurations are shown in FIGS. 6 a-e.

It is contemplated that the encasement 26 comprises a material suitablefor use with marking and aspiration of tissue and comprises a materialalso suitable for use with a delivery device 10. It should beappreciated that the encasement may be rigid or flexible and maycomprise an additional layer or otherwise use a material to reducesurface friction with the delivery tube during deployment. In onexample, the material of the encasement comprises an elastic material soas to receive a portion of the clip 22 as it is compressed into theencasement and placed in the delivery tube 16. In another example, thematerial is pliable so as to allow the clip to expand from within theencasement to a location exterior to the encasement. In yet anotherexample, the material is biodegradable, bioerodible, another suitabletime release material or otherwise configured to diminish in volume overtime so as to release agents into the tissue, release the clip fromwithin the encasement and attain its designed shape, a combinationthereof or otherwise.

Suitable material that may be used to form the encasement includesplastics such as bio-compatible polymer, starches, salts, or the like.Other suitable materials include implantable metals such as stainless orsurgical steel, a nickel containing metal, titanium or any other lowcorrosion biocompatible material. Still other suitable materials includenon-ferromagnetic metal (such as titanium) that does not create artifactwhen imaging breast tissue, or the like, through magnetic resonanceimaging (MRI).

The encasement 26 may include at least one first material in a matrix ofa second material. It may include a single material or it may be acapsule that contains one or a plurality of items or phases of matterwithin its interior.

Optionally, as stated above, the encasement 26 may comprises one or moreadditional layers, materials, agents or otherwise to facilitate in themarking or treatment of a tissue. Examples, of additional materials areselected from lubricants, collagen, antibiotics, antiseptics, radiationseeds, chemotherapeutic agents, thrombosis activating agents,combinations thereof or otherwise.

Advantageously, the encasement, clips or otherwise comprises a materialthat is detectable using ultrasonic technology, radiography, tomography,magnetic resonance imaging, combinations thereof of the like. Examplesof suitable encasements of the present invention includes pledgets,Gelfoam®, collagen, or the like.

In an alternative embodiment, it is contemplated that the encasement 26may be used alone or with a clip to further assisting in the treatmentof tissue. In one example the encasement may be utilized with a RadioFrequency Identification (RFID) device, or other element for location orproximity sensing, to assist in identification of previous medicaltreatment performed on a select tissue region. A RFID implant or othersuitable electronic device, for example might be adapted to storeinformation about a patient's medical history that can be retrievedsubsequently. Thus a patient effectively becomes a walking medical file.In another example, the encasement may be used with cryoblation toassist in neutralizing portions of a tissue region through freezing orheating the tissue, with the use other associated equipment. In yetanother example, the encasement 160 may be used chemotherapeutic agentsthat may be timed release or released via a remote controller orotherwise. In still another example, the encasement may comprise a chipor other sensing device for monitoring the growth of surrounding tissueand other matter, and optionally for providing and output signal oractivating a medicinal release device in the event abnormalities aresensed. In still another example, the encasement may be used withbrachytherapy, wherein the encasement releases radioactive seeds for thetreatment of cancer. Combinations of any of the above uses are alsocontemplated.

It is contemplated that the clip 22 and the encasement 26 of the presentinvention comprises separate components or comprises a single componentintegrally formed.

It is further contemplated that other emerging technologies are withinthe scope of the present invention. For example, the present inventionmay further include cytologic or histologic technology, which provides aimmediate testing (e.g., pathological testing) of a tissue sample whilethe delivery device, needle or both are still inserted into a tissuesample. As such, with the contemporaneous testing of a tissue sample,immediate measures can be taken to begin treatment of the tissue iffound harmful. This is most advantageous when it is determined that thetissue is malignant or otherwise places the host in harm and the host isa non-surgical candidate.

For example, during excising of a tissue sample of a non-surgicalcandidate it is determined that the tissue is malignant or otherwiseharmful, it is possible to insert an encasement, which may or may nothave a clip, to begin treatment of the tissue as discussed herein.

It will be appreciated that the present invention employs a devicesubstantially as disclosed in commonly invented and owned U.S. patentapplication Ser. No. 10/631,204 filed on Jul. 31,2003 and U.S.Provisional Patent Application Ser. No. 60/547,844 filed on Feb. 26,2004, hereby incorporated by reference, and various features and methodsof use as advanced herein are inherent in the disclosure of the priorapplication. Any redundancy of disclosure herein is not an admission ofa deficiency in such prior disclosure, but is provided in an abundanceof caution and to help articulate benefits achievable with the subjecttechnology.

Unless stated otherwise, dimensions and geometries of the variousstructures depicted herein are not intended to be restrictive of theinvention, and other dimensions or geometries are possible. Pluralstructural components can be provided by a single integrated structure.Alternatively, a single integrated structure might be divided intoseparate plural components. In addition, while a feature of the presentinvention may have been described in the context of only one of theillustrated embodiments, such feature may be combined with one or moreother features of other embodiments, for any given application. The useof different material combinations than those shown might also beappropriate, such as the substitution of metal for plastic, or plasticfor metal. It will also be appreciated from the above that thefabrication of the unique structures herein and the operation thereofalso constitute methods in accordance with the present invention.

The preferred embodiment of the present invention has been disclosed. Aperson of ordinary skill in the art would realize however, that certainmodifications would come within the teachings of this invention.Therefore, the following claims should be studied to determine the truescope and content of the invention

1. An improved device for deploying a clip to a biopsy site, comprising:a needle having a side opening; a tube having a leading portion with aforward end and a side opening having a center, wherein the forward endof the leading portion is located at a distance of about 8 to 16 mm fromthe center of the side opening; an elongated driver having an endportion located within the tube, the driver being adapted to slidewithin the tube to a position proximate to the side opening of the tube;and the clip is at least partially encapsulated and is located in thetube and axially forward of the elongated driver, wherein the needle isa piercing needle having a hollow portion configured for receiving thetube so that during deployment of the encapsulated clip to the biopsysite the needle houses at least a portion of the tube and at least aportion of the driver; wherein upon sliding the end portion of theelongated driver to a position proximate of the side opening the clip isdeployed precisely to the biopsy site without the need to longitudinallyre-position the needle and without having to longitudinally re-positionthe tube.
 2. (canceled)
 3. The improved device of claim 2, wherein thepiercing needle has a gauge of about 8 to 14, and the piercing needle isconfigured for aspiration, tissue removal, or a combination thereof. 4.The improved device of claim 3, wherein the tube has a gauge of about 9to 15, and the encasement has a diameter of between about ⅓ mm to about2½ mm.
 5. (canceled)
 6. The improved device of claim 4, wherein theencasement includes one or more additional layers, materials, or agentsto facilitate in the marking or treatment of a tissue region. 7-20.(canceled)
 21. The improved device of claim 4, wherein the encasementincludes a thrombosis activating agent.
 22. The improved device of claim4, wherein the encasement is generally cylindrical and maintains itssize, shape, or both over time.
 23. The improved device of claim 4,wherein the encasement is bioerodible, biodegradable, or both.
 24. Theimproved device of claim 6, wherein the encasement includes collagen.25. An improved device for deploying a clip to a biopsy site,comprising: a) an elongated delivery tube having a longitudinal axis, aleading portion with a forward end, and an opening, having a center, ina sidewall of the elongated delivery tube axially spaced from theleading portion; b) an elongated push rod including a portion thatslides within the elongated delivery tube and within the opening in thesidewall of the elongated delivery tube; c) the clip is at leastpartially encased and is located in the elongated delivery tube andaxially forward of the push rod; d) a ramp guide surface located in thetube, and inclined so that the ramp guide surface defines a rear end ofthe leading portion of the opening in the sidewall of the elongateddelivery tube, wherein upon sliding the elongated push rod to a positionproximate of the side opening the clip is deployed precisely to thebiopsy site without the need to longitudinally re-position the tube;wherein the center of the opening in the sidewall of the elongateddelivery tube is located about 8 mm to about 16 mm from a forward end ofthe leading portion.
 26. The improved device of claim 25, furtherincluding a piercing needle with a side opening, wherein the improveddevice for deploying a clip to a biopsy site is inserted at leastpartially into the piercing needle so that the clip can be inserted intothe biopsy site.
 27. The improved device of claim 25, wherein the rampguide surface is flat and terminates at a point that is axially offsetfrom the forward end of the side opening of the piercing needle.
 28. Theimproved device of claim 25, wherein the clip has a structure ofgenerally two back to back C shaped segments while in a pre-deploymentstate and a post-deployment state.
 29. The improved device of claim 28,wherein the encasement is between about ⅓ mm and about 2½ mm indiameter.
 30. The improved device of claim 28 wherein the push rodextends into the opening in the sidewall of the elongated delivery tubeso that the push rod pushes the clip up the ramp and into the biopsysite.
 31. The improved device of claim 30, wherein the tube has a gaugeof about 8 to
 14. 32. An improved device for deploying a clip to abiopsy site, comprising: a) an elongated delivery tube having alongitudinal axis, a leading portion with a forward end, and an opening,having a center, in a sidewall of the elongated delivery tube axiallyspaced from the leading portion; b) an elongated push rod including aportion that slides within the elongated delivery tube and within theopening in the sidewall of the elongated delivery tube; c) a ramp guidesurface located in the tube, and inclined so that the ramp guide surfacedefines a rear end of the leading portion of the opening in the sidewallof the elongated delivery tube; d) the clip is located in the elongateddelivery tube and axially forward of the push rod, wherein upon slidingthe push rod to a position proximate of the side opening the clip isdeployed precisely to the biopsy site without the need to longitudinallyre-position the tube; wherein a center of the opening in the sidewall ofthe elongated delivery tube is located about 5 mm to about 10 mm from aforward end of the leading portion, and wherein the clip includes anencasement that at least partially surrounds the clip so that theencasement protects the clip from forces encountered during deploymentof the clip.
 33. The improved device of claim 32, further including apiercing needle with a side opening, wherein the elongated delivery tubeis inserted into the needle so that the clip can be inserted into thebiopsy site.
 34. The improved device of claim 32, wherein the push rodis configured so that during deployment the end of the rod extends tothe end of the tube and through the opening in the sidewall of theelongated delivery tube.
 35. The improved device of claim 32, whereinthe clip extends along an axis between a first end and a second end andcomprising a metal structure consisting essentially of: a first arcsegment having a first end located at the first end of the clip and asecond end located at the send end of the clip; a second arc segmenthaving a first end located at the first end of the clip and a second endlocated at the second end of the clip, the second arc segment beingcoplanar with the first arc segment; the encasement includes orcomprises agents adapted to assist in the treatment of tissue; and anapex disposed along the clip axis defining where the first and secondarc segments adjoin and converge; wherein, after being driven throughthe opening in the sidewall of the elongated delivery tube, the metalstructure is configured to engage breast tissue, and the metal structureis configured so that (i) it resides entirely within the elongateddelivery tube prior to being driven through the opening in the sidewallof the elongated delivery device, (ii) it deploys through the opening inthe sidewall of the elongated delivery device, and (iii) in both anoriginal pre-deployment state and a post-deployment state: the firstends of the first and second arc segments project in a direction outwardrelative to the clip axis, and the second ends of the first and secondarc segments project in a direction outward relative to the clip axis,and the first ends of the first and second arc segments project in adirection generally away from the second ends of the first and secondarc segments; (iv) while it resides within the delivery tube prior tobeing driven through the opening in the sidewall of the elongateddelivery device, and after being driven through the opening in thesidewall of the elongated delivery device the first and second arcsegments are arcuate; and (v) the first ends and the second ends of thefirst and second arc segments engage breast tissue after being driventhe opening in the sidewall of the elongated delivery device, andthereby substantially prevent migration of the deployed clip within thebreast.
 36. The improved device of claim 33, wherein the leading portionis configured so that the clip when deployed will enter a central regionof a specific tissue of interest with substantially no adjustment of thedelivery device within the piercing needle.